Senior regulatory affairs specialist

hace 2 semanas


Sant Joan Despí, España ARTHADA A tiempo completo
Descripción de la oferta

ARTHADA, empresa líder en ofrecer servicios especializados de recursos humanos al sector farmacéutico, selecciona para un importante grupo Químico-Farmacéutico internacional en el área de los Genéricos un

Se responsabilizará de la elaboración de los expedientes de registro de especialidades farmacéuticas genéricas para aquellos países dónde la empresa o sus clientes deseen comercializar sus productos, principalmente entorno EMA y FDA. Mantendrá el contacto con los departamentos internos de la compañía y las empresas cliente. Asimismo, se ocupará de las variaciones y renovaciones. Responderá a las deficiency letters.

  • Licenciatura en Ciencias de la Vida.
  • Experiencia redactando dosieres de registros de productos farmacéuticos, principalmente módulo 3.
  • Experiencia en entorno EMA y/o FDA.
  • Capacidad de trabajo y dinamismo.
  • Dotes de planificación y organización.
  • Elevada capacidad de comunicación y trabajo en equipo.
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